MS Product Ads Kept On Short (Study) Leash As Avonex Draws FDA Letter
This article was originally published in The Pink Sheet Daily
FDA says a chart on Biogen Indec’s website implies Avonex is superior to Copaxone, Rebif, Betaseron and Extavia; the notice of violation was issued the same day FDA sent a warning letter to Teva citing its Copaxone promos.
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The agency sent Validus Pharmaceuticals a letter objecting to web pages that minimize the risk of suicidality with use of the bipolar disorder drug and suggest it does not worsen depression or induce weight gain.
The first warning letter of the year from FDA’s Office of Prescription Drug Promotion goes to Teva for web pages and materials displayed at a medical conference that overstated the safety and efficacy of its MS drug Copaxone.
MS drug spending is skyrocketing due to premium-priced new drugs and defensive price hikes across the category, making the therapeutic area a management priority for payers. Insurers are largely relying on aggressive contracting with manufacturers to manage the category, but new launches are unlikely to secure preferred formulary placement without comparative safety and efficacy data.